Alteogen Absorbs Subsidiary for Biosimilar Showdown... Head-to-Head with Samchundang Pharm

59% of Merged Subsidiary's Sales Comes from Eylea Biosimilar
Samchundang Pharm, Ahead in High-Dose Development, Targets Approval in 2028
Higher Patent Barriers for High-Dose Products Are a Key Factor Going Forward

The head-to-head competition between Alteogen and Samchundang Pharm in the market for high-dose (8 mg) Eylea biosimilars is now gathering pace. Alteogen is set to take direct charge of the product’s development through commercialization after absorbing its subsidiary Alteogen Biologics, which has handled clinical trials, regulatory approvals, and licensing agreements for the Eylea biosimilar.

According to the independent valuation opinion on the merger of Alteogen and Alteogen Biologics, the subsidiary posted sales of KRW 20.49 billion in the first half of this year. Sales of ALT-L9, a 2 mg Eylea biosimilar, totaled KRW 12.09 billion, accounting for about 59% of the total. The high-dose follow-on product ALT-L9F is targeted for commercialization in 2032. The valuation firm projected that ALT-L9F sales would rise from KRW 150.5 billion in 2032 to KRW 286.6 billion in 2036. It forecast that the product would account for more than half of the company’s estimated total sales in 2036.

Eylea is a treatment for wet retinal diseases developed by U.S.-based Regeneron and Germany’s Bayer. Its global sales reached about $9.5 billion in 2024, equivalent to approximately KRW 13 trillion. Following the expiration of the substance patent, 2 mg biosimilars began launching one after another in 2024. Regeneron had already introduced a high-dose product with a longer dosing interval in 2023.

Sales of the original product are shifting toward the high-dose version. In Regeneron’s U.S. sales for the second quarter of this year, the 8 mg product Eylea HD recorded sales of $596 million, or approximately KRW 800.3 billion. For the first time, it surpassed the 2 mg product, which generated $412 million. Eylea HD’s share of U.S. Eylea sales rose from 34% to 60% in one year.

Samchundang Pharm is the furthest along in developing a high-dose product in South Korea. The company is targeting approval for a high-dose version of SCD411 in the second half of 2028, about four years earlier than Alteogen’s target. Its U.S. and Latin American licensing agreement with Fresenius Kabi, signed in 2024, also includes the 8 mg product. Attention is also focused on whether Samsung Bioepis and Celltrion, which entered the 2 mg market first, will move into the high-dose market.

The biggest variable is Regeneron’s patent portfolio. Even in the 2 mg market, most South Korean developers secured launch dates through patent settlements with Regeneron. Samsung Bioepis and Celltrion reached settlements after U.S. courts issued injunctions barring sales. Samchundang Pharm, which has promoted its proprietary formulation, also reached settlements this year in the United States, Europe, South Korea, and Japan.

The patent barriers for high-dose products are higher. Formulation patents remain in force until around 2039. Regeneron also registered a method-of-treatment patent in 2024 covering the administration of approximately 8 mg or more in a volume of 100 microliters or less. Even if a company changes the formulation, it must still clear separate patents covering the dosage and method of administration. “The original high-dose product was approved only recently, so there are many new patent-related uncertainties,” an industry official said.

Alteogen says it does not expect a series of patent lawsuits, as it has filed an international patent application (PCT) for its technology to formulate a high-dose version of aflibercept, the active ingredient in Eylea.

This content was produced with the assistance of AI translation services.